Specialist, Regulatory Affairs

  • Company: Johnson & Johnson
  • Location: Warsaw, Indiana
  • Posted: March 01, 2017
  • Reference ID: 9375170208-en-us

Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Specialist, Regulatory Affairs, located in Warsaw, IN.
Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales.  The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products. 
Principal Responsibilities:
  • Provides expertise in foreign regulatory requirements
  • Manages and/or coordinates regulatory submissions and files, including 510(k)s, PMAs, PMA supplements, IDEs, Minor Modifications, STEDs, EU technical files, design dossiers, and technical file revisions.
  • Coordinates and submits licenses and authorizations for the maintenance of existing products, international registrations, and dossiers
  • Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance
  • Responds to product information requests
  • Researches and collects information and data to support periodic reports to regulatory agencies
  • Provide Regulatory Affairs support during internal and external audits
  • Assists in the development of best practices for Regulatory Affairs processes
  • Represents Regulatory Affairs on cross-functional project teams

  • A minimum of a Bachelor’s Degree is required.  A focused degree in biological sciences, bioengineering, and/or related medical/health fields is preferred.  An advanced degree is preferred
  • A minimum of 3 years of Regulatory Affairs experience in a regulated healthcare environment or industry is required (Candidates with <3 years of practical experience who currently possess an advanced degree in Regulatory Affairs will also be considered)
  • Experience with US FDA Regulations and European Medical Device Directives preferred
  • Experience in worldwide regulatory systems is preferred
  • Demonstrated expertise in medical device regulatory requirements and processes is preferred.
  • Demonstrated expertise in orthopaedics and orthopaedic device regulatory requirements is preferred.
    BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location
United States-Indiana-Warsaw
Depuy Orthopaedics. Inc. (6029)
Job Function
Regulatory Affairs
Requisition ID

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